Ethical Considerations of Gene Therapy

10 Key excerpts on "Ethical Considerations of Gene Therapy"

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  Gene Therapy: Prospective Technology assessment in its societal context

  • Jörg Niewöhner, Christof Tannert(Authors)
  • 2011(Publication Date)
  • Elsevier Science

    (Publisher)

  [36] Resnik, D., Langer, P.J., Steinkraus, H.B. Human Germline Gene Therapy: Scientific, Moral and Political Issues. R.G. Landes, Austin, 1999.

  [37] Smith, K. R. Gene therapy: Theoretical and bioethical concepts. Arch. Med. Res. . 2003; 34:247–268.

  [38] Grün, M. K., Morsey, B. Prospektive Gesetzesfolgenabschätzung zum Problembereich somatische Gentherapie . Speyer: Forschungsinstitut für öffentliche Verwaltung; 1997.

  1 Proposed in utero treatments are not discussed here as another contribution concentrates on fetal gene therapy.

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  “Ghost of Christmas Past” …Eugenics and other Moral Dilemmas Surrounding Genetic Interventions: A Discussion in the Context of Virtue Ethics

  Agomoni Ganguli,     Ethics Centre, University of Zurich, Switzerland

  Publisher Summary

  This chapter provides an insight into the history of Eugenics and its influence on current debate surrounding gene therapy and other genetic technologies. Eugenics first came to light as an ideology concerned with improving the health and moral constitution of mankind. Based on a thoroughly incomplete knowledge about human heredity, a lack of respect for the individual, and driven forward by economic and social pressures, it became the cause of some of the worst forms of coercion and atrocities known in history. The ghost of Eugenics comes out of the closet every time the techniques that might intervene in human reproduction are discussed. Eugenecists not only discouraged the spread of “inferior” genes, but also encouraged the spread of “superior” genes and traits. Morality in general and the ethics of genetic interventions, regarding both therapy and enhancement, ultimately lie in the motives of those who are directly concerned: the parents, the scientists, the doctors, and the rest of individuals choosing to embrace or selectively reject the possibilities created by biotechnology.

  Abstract

  It is never an easy task to talk about the moral dilemmas surrounding a technology that is still far from becoming an established medical procedure. One always runs the risk of either stating the obvious pitfalls of medical technologies or being tempted to speculate and be dismissed as having too wild an imagination. However, reproductive technologies, even at their embryonic stages, continue to stroke our hopes and fears and it is worth discussing them even when we have an unclear picture of what the future holds.In the first part, this paper looks at the history of Eugenics and its influence on current debate surrounding gene therapy and other genetic technologies. Then, pointing out the blurred distinction between therapy and enhancement, it goes on to discuss the various moral dilemmas in the context of virtue ethics.

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  Gene Therapy

  • Evelyn B. Kelly(Author)
  • 2007(Publication Date)
  • Greenwood

    (Publisher)

  S E C T I O N T W O Ethics and Regulations The year 2001 began the first decade of the new millennium with a cascade of weighty biomedical issues confronting the citizens and government of the modern United States. Other countries also struggled with ethical and regulatory issues. Section Two, consisting of Chapters 9 through 13, considers issues related to the ethics and regulation of gene therapy research. Both sides are presented. Some issues appear in the news media; others are debated only in medical circles. It is not the intent of this book to take a position one way or another but to present per- spectives in an unbiased manner. Issues relating to medical ethics, religion, and regulation are presented. Com- pelling questions posed in this section include the following: • What is the meaning of bioethics as it relates to gene therapy? • What is the likely impact of gene therapy on people’s regard for the sanc- tity of human life? • What are the risks of inadvertently treating the germ lines? • How safe must an experiment be before it is ethical to try on humans? • What alternative methods of treatment are available? • Is gene therapy likely to be more effective, less costly, or otherwise more acceptable than other available treatments? • How adequate is the review process that governs gene therapy trials? • What does informed consent mean for gene therapy trials? • Do the types of people who volunteer types for gene therapy need address- ing? • Could there be a deliberate misapplication of procedure? • Are side effects of the treatment reversible or treatable in the patient and in the population? • Do doctors and scientists have conflicts of interest? Chapter 9 discusses ethical precepts that must be considered in gene therapy experiments. Chapter 10 presents regulation efforts in the United States, Chapter 11 discusses gene therapy activities in other countries. and Chapter 12 looks at social and religious considerations.

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  Molecular Medicine

  Genomics to Personalized Healthcare

  • R.J. Trent(Author)
  • 2005(Publication Date)
  • Academic Press

    (Publisher)

  The Journal of the American Medical Association . 2001; 285:545–550.

  (summarises the difficult political and regulatory issues interacting with ethical discussions on stem cells ). Orive, G, Hernandez, RM, Gascon, AR, Igartua, M, Pedraz, JL. Controversies over stem cell research. Trends in Biotechnology . 2003; 21:109–112.

  Spink, J, Geddes, D, Gene therapy progress and prospects: bringing gene therapy into medical practice: the evolution of international ethics and the regulatory environment. Gene Therapy 2004; 11:1611–1616 (provides an overview of different national ethical and regulatory issues in gene therapies ).

  Government

  31. http://www.4.od.nih.gov/oba/rac/guidelines/guidelines.html

  32. http://www.fda.gov/cber/infosheets/genezn.htm (a summary of the role of the FDA in human gene therapy ).

  Future

  (illustrates how criteria can be developed to determine the value of a DNA test ). Burke, W, Pinsky, LE, Press, NA. Categorizing genetic tests to identify their ethical, legal and social implications. American Journal of Medical Genetics . 2001; 106:233–240.

  (views are expressed about the patenting of stem cells and how this might alienate public opinion ). Caulfield, TA. From human genes to stem cells: new challenges for patent law? Trends in Biotechnology

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  The CliniBook

  Clinical gene transfer state of the art

  • Odile Cohen-Haguenauer(Author)
  • 2012(Publication Date)
  • EDP Sciences

    (Publisher)

  Even so, it is undoubtedly true that the determination to move into humans is neces- sarily affected by the nature of the disease, the available alternatives, the scientific con- Ethics in translation from research to therapy 497 text, and many other factors that may be better understood by patient-subjects than by investigators or even treating physicians. Gene transfer research has helped to high- light the importance of these factors and the complexities of the decision to move into the clinic by virtue of the unprecedented scrutiny given to it worldwide, both as a result of the public deliberations of oversight bodies like the Recombinant DNA Advisory Committee (RAC) of the National Institutes of Health in the US and the Gene Ther- apy Advisory Committee in the UK, and because of some highly publicized deaths and severe adverse events in trials around the world and the resulting media attention. DECISIONS IN AN IMPERFECT WORLD A tentative stratification scheme The biggest ethical challenge for gene transfer research lies in moving forward with this logical, scientifically promising, and highly complex technology, with the hope of ultimately developing interventions with the capacity to reduce or relieve symptoms, prolong life, or perhaps even cure, but without waiting for certainty. The primary duties of investigators toward their research subjects are (1) to protect them from undue harm and (2) to avoid disadvantaging them by depriving them of the chance to benefit from established treatments. With the safety of patient-subjects foremost, then, determining how best to move forward means deciding when to go forward and which patient-sub- jects should go first. From whom may the most be learned at the least risk to them? Very sick subjects may be at greater risk of harm, but may value the chance of benefit highly. However, the effects of the disease, of the intervention, and of prior treatment may be difficult to disentangle in very sick subjects.

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  Between Science and Values

  • Loren R. Graham(Author)
  • 2019(Publication Date)
  • Columbia University Press

    (Publisher)

  . . treating the genes [in these instances] will raise no unusual moral questions, no issues not already present in investigational thera-peutic trials, or hazardous or last-ditch surgery of other sorts. 22 Ramsey was analyzing here a hypothetical situation in which a reliable and safe means of treating serious individual gene defects had already been worked out. Theodore Friedmann and Richard Roblin of the Salk Institute for Biological Studies warned in 1972 in Science that this situation does not yet exist: For an acceptable genetic treatment of a human genetic defect, we would require that the gene therapy replace the functions of the defective gene BIOMEDICAL ETHICS 279 segment without causing deleterious side effects either in the treated individual or in his future offspring. Years of work with tissue cultures and in experimental animals with genetic defects will be required to evaluate the potential side effects of gene therapy techniques. In our view, solutions to all these problems are needed before any attempt to use gene therapy in human patients could be considered ethically acceptable. 23 These same authors called for researchers not to attempt gene therapy in human patients unless the following criteria are met: 1. There should be an adequate biochemical characterization of the prospective patient's genetic disorder. For example, if a person seems to be suffering from lack of a certain normal protein, one should determine in advance of genetic therapy whether the patient is not producing enough of the protein due to genetic defect, or has an inability to utilize the protein even though it is being produced. 2. There should be prior experience with untreated cases of what appears to be the same genetic defect so that the natural history of the disease and the efficacy of alternative therapies can be assessed.

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  Genomes, Evolution, and Culture

  Past, Present, and Future of Humankind

  • Rene J. Herrera, Ralph Garcia-Bertrand, Francisco M. Salzano(Authors)
  • 2016(Publication Date)
  • Wiley-Blackwell

    (Publisher)

  Even philosophers Robert Nozick and Michael Sandel who don't agree on basic theories of justice agree that there are some things we should probably not be pursuing because of their possible consequences. Nozick [43] says that restrictions on liberty might be justified when it is necessary to prevent a disaster. Sandel suggests that genetic enhancement seems more intrusive and sinister than other forms of enhancement that we provide to our children, and he stresses the inequity that could ensue and threaten our appreciation of life as we currently know it [40].

  Ethical Issues Associated with Medical Technology

  Natural selection is relatively slow in comparison with cultural, technical, and environmental changes imposed by humans. Disease will continue to exert strong selection pressures but many of these pressures will be eliminated by modern medicine. Current and evolving medical technologies will continue to ensure a longer life span and the ability to reproduce. Therapeutic interventions for genetic diseases are already being used to treat or cure diseases at the prenatal, neonatal, childhood, and adult stages of life. These interventions include gene therapies (mRNA, gene insertion), stem cell therapy, biosimilars, pharmaceuticals, and surgical procedures. Many of the conditions would be fatal if not treated and so treatments or cures allow the detrimental alleles responsible for the disease phenotype to persist in the population, and may eliminate resistant alleles.

  Gene Therapy

  Gene therapy brings together molecular biology and clinical medicine and is the most controversial of the genetic treatments. Human gene therapy is the process of introducing a “normal” gene into an individual's cells or tissues for the purpose of treating or curing a genetic disease. The gene inserted into the patient is usually the wild-type form of the gene that is used to compensate for the patient's mutant allele(s). The genes are usually delivered through a vector that usually is an attenuated virus. Virulent genes are removed from the virus and the gene to be delivered is placed inside the viral vector [44].

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  CRISPR-/Cas9 Based Genome Editing for Treating Genetic Disorders and Diseases

  • Luis María Vaschetto(Author)
  • 2022(Publication Date)
  • CRC Press

    (Publisher)

  Table 3 highlights some arguments in favor and against genome editing for enhancement of human traits.

  Table 3. Genome editing and human enhancement

  Pros	Against
  Treatment and prevention of diseases and disorders	Uncertainty about off-target effects Increase of human inequalities
  Enhancement of human performance	Concerns related to the alteration of human nature (germ-line genome modification)

  Xenotransplantation

  Xenotransplantation refers to the process of transplantation of organs, tissues or cells from one species to another. The xenotransplantation of animal organs to humans is seen as a solution to overcome the worldwide donor organ shortage. The second World Health Organization (WHO) Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials (2011) developed a series of guidelines and recommendations for xenotransplantation: “Investigators must ensure that source animals are bred for the purpose and as safe as possible, using a closed colony of consistently known specific pathogen-free animals housed in a well-controlled pathogen-free environment with high levels of biosecurity”. Indeed, the main problems that this technique faces are the risk of infection caused by zoonotic pathogens and rejection by the immune system. Moreover, diverse animal models for the study of human diseases have been developed using CRISPR-Cas technology (Shah et al. 2018 ). For example, CRISPR-Cas9 has allowed to inactivate endogenous retroviruses from genetically modified pigs (Niu et al. 2017

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  Gene Therapy

  Developments and Future Perspectives

  • Chunsheng Kang(Author)
  • 2011(Publication Date)
  • IntechOpen

    (Publisher)

  Almost half a century later, the initial enthusiasm and euphoria have been greatly tempered by the sober recognition that while gene therapy is simple in concept, it is highly complex and challenging in execution. The early promises of human gene therapy raised unrealistically high expectations that gene medicine was round the corner. Compounded by well publicised serious iatrogenic complications from a small number of clinical trials, a pall quickly descended on the field from the late 1990s that led many investigators to flee from a field of research that came to be perceived as both unfeasible and unfundable. Gene therapy has now emerged from a much needed phase of reflection and correction. There is clear evidence that appropriately selected monogenic and acquired diseases can benefit from gene-based therapy. Notwithstanding that there remains a risk to certain viral vectors, the decision to reinitiate gene therapy trials for SCID-X1 (NCT01129544) is acknowledgement of what gene therapy may offer to diseases that are currently difficult to treat effectively or at reasonable cost. Failures of gene therapy should not discredit the field but ought to be opportunities to deepen scientific understanding of the complex processes demanded for therapeutic success. Safety is a key consideration, particularly with respect to genotoxicity. The confluence of autologous cell therapy with conventional gene therapy appears to be a promising approach. Cells that are first modified ex vivo lend themselves readily to comprehensive biosafety assessments that are not feasible with conventional in vivo gene therapy. The ability to thoroughly characterize cells for the desired phenotype, and for genotoxicity and other risks before in vivo implantation or administration should go some way to making such novel treatments safe. (The authors were unable to cite all relevant publications owing to page limitations.) Gene Therapy - Developments and Future Perspectives 176 6.

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  Introduction to Molecular Biology, Genomics and Proteomics for Biomedical Engineers

  • Robert B. Northrop, Anne N. Connor(Authors)
  • 2008(Publication Date)
  • CRC Press

    (Publisher)

  11 Ethical Issues in Genetic Engineering . INTRODUCTION When.there.is.a.trade-off.between.costs.and.benefits,.there.will.always.be.a.debate.(often.heated). about.how.to.proceed . .One.source.of.this.controversy.is.that.there.is.a.lack.of.universal.agreement. on.what.is.a.cost.and.what.is.a.benefit.for.a.given.issue . .Individuals.assign.different.weights.to.per-ceived.costs.and.benefits . .Ethical.debate.in.the.fields.of.molecular.biology.and.genetics.is.related. to.diverse.issues.such.as.novelty,.the.unknown,.religious.beliefs,.and.nascent.technical.abilities . . Individuals.considering.genetic.engineering.and.related.fields.would.be.well-served.to.develop.a. clear.ethical.framework.for.decision.making . . FRAMEWORK FOR ETHICAL DECISION MAKING In.considering.ethical.issues.in.the.biosciences,.it.is.helpful.to.have.a.theoretical.framework.for. addressing.ethics . .Although.it.is.beyond.the.scope.of.this.textbook.to.offer.a.full.treatment.of.ethi-cal.theory.(entire.courses.are.taught.on.this),.we.present.summaries.of.several.ethical.models . .The. models.discussed.in.the.following.text.offer.several.steps.to.guide.decision.making . .Note.that.these. models.do.not.end.with.the.initial.decision.but.include.a.step.to.follow.up.on.the.outcomes.of.one’s. decisions. .In.other.words,.these.models.indicate.that.ethical.persons.have.a.responsibility.for.assess-ing.the.results.of.their.choices . .A.major.difficulty.in.making.ethical.choices.in.genetic.engineering. is.that.we.cannot.always.foresee.all.consequences . .“The.law.of.unintended.consequences”.encap-sulates.the.idea.that.every.action.has.unintended.as.well.as.intended.outcomes,.sometimes.positive,. sometimes.harmful . .For.this.reason,.follow-up.is.especially.important . 11.2.1 D EFINING E THICS The. Markkula. Center. for. Applied. Ethics. at. Santa. Clara. University. has. published.

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  An Introduction to Ethical, Safety and Intellectual Property Rights Issues in Biotechnology

  • Padma Nambisan(Author)
  • 2017(Publication Date)
  • Academic Press

    (Publisher)

  Chapter 5

  Relevance of Ethics in Biotechnology

  Abstract

  Advances in biotechnology are rapidly determining the future of mankind, touching all aspects of life: from food, to healthcare and life expectancy, and environment. There is therefore a pressing need to examine the ethical ramifications of biotechnology research. The moral approach to science policy demands that we justify our actions, account for our intentions, and avoid being at the mercy of the “technological imperative” (employing a technique merely because we can). A critical examination of the moral value of the technology, whether it serves to protect individual rights and dignity, whether it is fair to all concerned so that the risks and benefits are shared equally, and whether it is for the common good, is necessary for both the scientist and the public.

  Keywords

  Values; morals; ethics; bioethics; biomedical ethics; consequentialism; utilitarianism; deontological ethics; categorical imperative; common morality; proportionality; subsidiarity; slippery slope; environmental ethics; terminator technology; 3Rs of animal ethics; human clinical trials; Tuskegee syphilis trials; Manhattan Project; thalidomide disaster; TeGenero clinical trial; Jesse Gelsinger; World Medical Association; Declaration of Geneva; Good Clinical Practices (GCP); Nuremberg Code; Belmont Report; International Bioethics Committee; International Association of Bioethics

  Ethics is knowing the difference between what you have a right to do and what is right to do. Potter Stewart, Associate Justice, United States Supreme Court

  Chapter Outline

  5.1 Introduction  128

  5.1.1 Ethics and Bioethics  129

  5.1.2 “Values,” “Morals,” and “Ethics”  129

  5.2 Theories in Ethics  129

  5.3 Promoting Ethically Sound Science  131

  5.4 Ethical Issues in Biotechnology  131

  5.4.1 Environmental Ethics  131

  5.4.2 Ethical Issues in Plant Biotechnology  132

  5.4.3 Animal Rights and the Use of Animals in Medical Research 

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